Who is the manufacturer of Custom Abutments?

Institut Straumann AG filed the 510(k) submission for Custom Abutments (K243278).

What is the FDA product code for Custom Abutments?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Custom Abutments?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Custom Abutments?

Straumann TLX CARES Abutments TAN (NT, RT, WT) (K200586).

Who can help prepare an FDA 510(k) submission like Custom Abutments?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Custom Abutments

K243278 · Institut Straumann AG · NHA · Feb 21, 2025 · Dental

Device Facts

Record ID	K243278
Device Name	Custom Abutments
Applicant	Institut Straumann AG
Product Code	NHA · Dental
Decision Date	Feb 21, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Straumann Custom Abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented.

Device Story

Custom Abutments are patient-matched dental abutments used to restore Straumann dental implants. The clinician performs an intraoral scan of the patient's anatomy; the design is created using Straumann-approved CAD/CAM software (e.g., Straumann CARES Visual). Design data is transmitted to a Straumann-validated milling center for fabrication. The abutments feature implant-specific connection geometries (SynOcta, CrossFit, or TorcFit) and are secured to the implant via a basal screw. The device includes options for angled screw channels (up to 25° from the implant axis, 20° screwdriver angulation) to optimize screw exit positioning for esthetics and function. The abutment supports cemented prosthetic restorations. The device is used in a dental clinic setting by a dentist or dental specialist. The output (the custom abutment) provides the structural interface between the endosseous implant and the final prosthetic crown or bridge, facilitating functional and esthetic tooth replacement.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including dynamic fatigue testing per ISO 14801:2016 on worst-case constructs, digital workflow validation, steam sterilization validation (ISO 17665-1/2), MRI compatibility testing (ASTM F2052, F2213, F2182, F2119), and biocompatibility assessment (ISO 10993-1).

Technological Characteristics

Materials: Ti6Al7Nb (ISO 5832-11) or CP Titanium (ISO 5832-2). Connections: SynOcta, CrossFit, TorcFit. Design: CAD/CAM customized. Angulation: Up to 25° screw channel. Sterilization: Supplied non-sterile, moist heat sterilized by end user. Usage: Single-patient, single-use. Connectivity: Digital design data transfer to centralized milling center.

Indications for Use

Indicated for single tooth replacement and multiple tooth restorations in patients requiring dental implant-supported prosthetic reconstructions. Contraindications include patients where standard dental implant procedures are not suitable.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Predicate Devices

Straumann TLX CARES Abutments TAN (NT, RT, WT) (K200586)

Reference Devices

Straumann BLX CARES Titanium Alloy (TAN) Abutments (K190040)
Straumann CARES Titanium Abutment (RN) (K052272)
Straumann Variobase for Crown AS (K173379)
Medentika CAD/CAM Abutments (K150203)
MRI Compatibility for Existing Straumann Dental Implant Systems (K190662)
Straumann TLX Novaloc and Cementable Abutments (K203355)

Related Devices

K253341 — Custom Abutments AS · Medentika GmbH · Dec 23, 2025
K150899 — Straumann CARES Titanium Alloy (TAN) Abutment · Straumann USA, LLC · Sep 16, 2015
K231307 — Elos Accurate Customized Abutment · Elos Medtech Pinol A/S · Dec 21, 2023
K172798 — Straumann CARES Abutments CoCr · Institut Straumann AG · Jan 3, 2018
K181580 — Cortex CAD/CAM Abutments · Cortex Dental Implants Industries , Ltd. · Jan 29, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 21, 2025 Institut Straumann AG % Jennifer Jackson Sr Dir, Regulatory & Quality NAM Straumann USA. LLC 60 Minuteman Road Andover, Massachusetts 01810 Re: K243278 Trade/Device Name: Custom Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 6, 2024 Received: February 3, 2025 #### Dear Jennifer Jackson: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. {2}------------------------------------------------ For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Andrew I. Steen -S Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ### Indications for Use Submission Number (if known) #### K243278 Device Name Custom Abutments Indications for Use (Describe) The Straumann Custom Abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented. Type of Use (Select one or both, as applicable) < | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ #### Custom Abutments #### K243278 510(k) Summary ## 510(k) Summary ## Submitter's Contact Information | Submitter: | Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 Registration No.: 1222315 Owner/Operator No.: 9005052 | |---------------------|---------------------------------------------------------------------------------------------------------------------------| | | On the behalf of: Institut Straumann AG Peter Merian-Weg 12 4002 Basel, Switzerland | | Contact Person: | Jennifer M. Jackson, MS Director of Regulatory Affairs Phone Number: +1-978-747-2509 Fax Number: +1-978-747-0023 | | Prepared By: | Gordon Dodds, PhD Manager, Design Control Quality Management Phone number: +49 89 309075 291 | | Date of Submission: | February 20, 2025 | ## Name of the Device | Trade Names: | Custom Abutments | |------------------------|------------------------------------| | Common Name: | Endosseous dental implant abutment | | Classification Name: | Endosseous dental implant abutment | | Regulation Number: | §872.3630 | | Device Classification: | II | | Product Code(s): | Primary product code - NHA | ## Predicate Device(s) Primary Predicates: - K200586 Straumann TLX CARES Abutments TAN (NT, RT, WT) . Reference Devices: - K190040 Straumann BLX CARES Titanium Alloy (TAN) Abutments (RB, WB) . {5}------------------------------------------------ #### Custom Abutments K243278 510(k) Summary - K052272 Straumann CARES Titanium Abutment (RN) ● - K173379 Straumann Variobase for Crown AS ● - . K150203 – Medentika CAD/CAM Abutments - K190662 MRI Compatibility for Existing Straumann Dental Implant Systems ● - K203355 Straumann TLX Novaloc and Cementable Abutments . ## Device Description The Straumann Custom Abutments (previously named Straumann CARES Abutments) are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths and platforms. The Custom Abutments are patient-matched abutments; the customer scans the intraoral situation and designs the shape using a Straumann-approved CAD/CAM software (such as Straumann CARES Visual). The design data is then transferred to Straumann where the fabrication of the custom abutment is carried out at a Straumann validated milling center (FEI: 3024185724 or FEI: 3011221537). The existing Custom Abutments feature a straight screw channel for the basal screw which fixes the abutment to the respective implant. The purpose of this submission is to add Custom Abutments with an angled screw channel to the Straumann Custom Abutment Portfolio. The subject Custom Abutments can be designed and manufactured with an angled screw channel (as opposed to straight), so that the screwexit is located in a favorable position (away from the incisal/occlusal edge and tooth cusps) for esthetic and functional results. The screw channel can be angled, the screwdriver maximum angle is 20°. The Custom Abutments are designed for connection to implants of the Straumann Dental Implant System. The Custom Abutments have an implant-specific connection interface for the respective compatible implant. The Custom Abutments with the SynOcta geometry (RN or WN) are designed for connection to the Straumann Tissue Level (TL) implants. Those with the CrossFit geometry (NC or RC) are designed for connection to the Bone Level (BL) and Bone Level Tapered (BLT) implants. The Custom Abutments with the TorcFit geometry, are designed for connection to the Straumann Bone Level BLX and BLC (RB/WB or WB) or Tissue Level TLX and TLC (NT, RT, WT) implants. The basal screws feature threads to secure the abutment with the implant {6}------------------------------------------------ #### Custom Abutments #### K243278 510(k) Summary inner geometry. The basal screws also contain the connection geometry to mate with the AS screwdrivers for installation into the implant. ## Indications for Use Custom Abutments The Straumann Custom Abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented. ## Technological Characteristics The indications for use and technological characteristics of the subject devices are consistent with those of the primary predicate and reference devices as detailed in the following tables. {7}------------------------------------------------ ## Custom Abutments 510(k) Summary | Comparison | Custom Abutments | K200586 Straumann TLX CARES Abutments TAN | K190040 Straumann BLX CARES Titanium Alloy (TAN) Abutments | K052272 Straumann CARES Titanium Abutment (RN) | K150203 Medentika T and K Series Preface (CAD/CAM) Abutments | K173379 Straumann Variobase for Crown AS | Equivalence | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Straumann Custom Abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented. | The Straumann CARES Abutments TAN are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented. | The Straumann CARES Abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented on directly veneered/screw-retained. | Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann CARES Titanium Abutment is indicated for cemented restorations. The abutment can be used in single tooth replacements and multiple tooth restorations. | Medentika Preface CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Implant System Compatibility Dentsplv Friadent® Frialit/XiVE® Series T Implant Diameter (mm) 3.4, 3.8, 4.5, 5.5 Platform Diameter (mm) 3.4, 3.8, 4.5, 5.5 Nobel Biocare Brånemark System K Series Implant Diameter (mm) 3.3, 3.75, 4.0, 5.0 Platform Diameter (mm) 3.5, 4.1, 5.1 Medentika PreFace is intended for use with the Straumann® CARES® System. All digitally designed abutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® validated milling center. | The Straumann® Variobase® for Crown AS is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for Crown AS are indicated for screw retained single tooth or cement-retained single tooth and bridge restorations. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. All digitally designed copings and/or crowns for use with the Straumann Variobase® for Crown AS are intended to be sent to Straumann for manufacture at a validated milling center. | Equivalent; The indications statements all specify use in single tooth replacement and multiple tooth restorations. The The statement is only revised to replace CARES with Custom. The Medentika indications for use statement directly includes additional technical details that are consistent with the Straumann Custom Abutments abeling. | Table 2. Comparative summary of technological characteristics. | Comparison | Custom Abutments | K200586 Straumann TLX CARES Abutments TAN | K190040 Straumann BLX CARES Titanium Alloy (TAN) Abutments | K052272 Straumann CARES Titanium Abutment (RN) | K150203 Medentika T Series and K Series Preface (CAD/CAM) Abutments | K173379 Straumann Variobase for Crown AS | Equivalence | |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FDA product code | NHA | DZE, NHA | NHA | NHA | NHA | NHA | Identical | | Implant to abutment connection | SynOcta RN, WN CrossFit NC, RC TorcFit RB/WB, WB, NT, RT, WT | TorcFit NT, RT, WT | TorcFit RB/WB, WB | SynOcta RN | Medentika T Series Medentika K Series | SynOcta RN, WN CrossFit NNC, NC, RC | Equivalent; The Custom Abutments consist of previously cleared Straumann implant to abutment connections. | | Abutment Designs | Customized | Customized | Customized | Customized | Customized | N/A; Titanium base | Equivalent | | Prosthesis Attachment | Cement retained | Cement retained | Cement retained or directly veneered/screw-retained | Cement retained | Cement retained | N/A: Titanium base | Equivalent | | Restoration | Single unit Multiple unit | Single unit Multiple unit | Single unit Multiple unit | Single unit Multiple unit | Single unit Multiple unit | Single unit Multiple unit | Identical | | Compatible Implant Body Diameter (mm) | SynOcta 3.3-4.8 CrossFit 3.3-4.8 TorcFit 3.3-6.5 | TorcFit 3.75-6.5 | TorcFit 3.75-6.5 | SynOcta 4.8 | Dentsply Friadent® Frialit/XiVE® 3.4, 3.8, 4.5, 5.5 Nobel Biocare Brånemark 3.3, 3.75, 4.0, 5.0 | SynOcta 3.3-4.8 CrossFit 3.3-4.8 | Equivalent; A new implant body diameter of 3.3 is added for connection with the TorcFit connection. This additional diameter does not raise different questions of safety and effectiveness. Substantial equivalence is demonstrated by dynamic loading testing per ISO 14801. | | | | | | | | | | | Comparison | Custom Abutments | K200586 Straumann TLX CARES Abutments TAN | K190040 Straumann BLX CARES Titanium Alloy (TAN) Abutments | K052272 Straumann CARES Titanium Abutment (RN) | K150203 Medentika T Series and K Series Preface (CAD/CAM) Abutments | K173379 Straumann Variobase for Crown AS | Equivalence | | Abutment & Abutment Screw Materials | Ti6Al7Nb (TAN) conforming to ISO 5832-11 or commercially pure titanium conforming to ISO 5832-2 Basal screws are TAN conforming to ISO 5832-11 | TAN conforming to ISO 5832-11 | TAN conforming to ISO 5832-11 Cobalt-chromium alloy (coron®) | Commercially pure titanium conforming to ISO 5832-2 Basal screw is TAN conforming to ISO 5832-11 | Ti6Al4V, medical grade 5, conforming to ASTM F136 | TAN conforming to ISO 5832-11 | Equivalent; All Custom Abutments are offered in titanium or a titanium alloy. | | Sterilization | Supplied non-sterile Moist heat sterilized by end user | Supplied non-sterile Moist heat sterilized by end user | Supplied non-sterile Moist heat sterilized by end user | Supplied non-sterile Moist heat sterilized by end user | Supplied non-sterile Moist heat sterilized by end user | Supplied non-sterile Moist heat sterilized by end user | Identical | | Usage- All components | Single-patient, single-use | Single-patient, single- use | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use | Single-patient single-use | Identical | | Minimum wall thickness to screw channel (mm) | 0.5 | 0.33 | 0.4 | N/A-510(k) covers use with Sirona Inlab 3D design software | 0.4 | N/A; Titanium base | Equivalent The increased minimum wall thickness to screw channel does not raise different questions of safety and effectiveness. Substantial equivalence is demonstrated by dynamic loading testing per ISO 14801. | | Minimum gingival height (mm) | RB/WB 0.9 WB 0.5 NC 0.5 RC 0.5 NT, RT, WT 0.0 RN, WN 0.0 | NT, RT, WT 0.0 | RB/WB 1.0 WB 0.5 | N/A-510(k) covers use with Sirona Inlab 3D design software | T-Series 0.1 K Series 0 | N/A; Titanium base | Equivalent; The range of gingival heights within that of K150203. Note: The top of the tissue level implants are placed at the height of the gingiva, so the smallest gingival collar height is 0 mm. | | Maximum gingival height (mm) | RB/WB 4.5 WB 4.5 NC 3.5 RC 3.5 NT 4.6 RT 4.6 WT 4.6 RN 4.0 WN 4.0 | Not specified | Not specified | Not specified | Maximum gingival height 6mm | Not specified | Not specified | | Max angulation (degrees) | 30° | 30° | 30° | N/A-510(k) covers use with Sirona Inlab 3D design software | 30° | N/A; Titanium base | Equivalent | | Minimum abutment post height (mm) (length above the abutment collar/gingival height) | 4 | 4 | Not specified | N/A-510(k) covers use with Sirona Inlab 3D design software | 4 | N/A; Titanium base | Equivalent | | Minimum surface area (mm²) - considered after fulfilment of the specified minimum design limits | 37, 43, 47 & 56 dependent on tooth position | 37, 43, 47 & 56 dependent on tooth position | 37, 43, 47 & 56 dependent on tooth position | N/A-510(k) covers use with Sirona Inlab 3D design software | 37, 43, 47 & 56 dependent on tooth position | N/A; Titanium base | Identical | | Max screw channel angulation (degrees) | 25° from the knee point (screwdriver maximum angulation of 20°) | Straight | Straight | Straight | Straight | The titanium base provides possibility for an angled screw channel (up to 25° from the implant axis corresponding to a screwdriver angulation of 20°) in the coping and/or crown. | Equivalent | | Design workflow | Computer aided design (CAD) | Computer aided design (CAD) | Computer aided design (CAD) | Computer aided design (CAD) | Computer aided design (CAD) | N/A; Titanium base | Equivalent | | Manufacturing workflow | Milled at Straumann CARES validated milling center | Milled at Straumann CARES validated milling center | Milled at Straumann CARES validated milling center | Milled at Straumann CARES validated milling center | Milled at Straumann CARES validated milling center | N/A; Titanium base | Equivalent | {8}------------------------------------------------ ## Custom Abutments 510(k) Summary {9}------------------------------------------------ #### Custom Abutments 510(k) Summary ## Materials The abutments are manufactured from titanium alloy conforming to ISO 5832-11:2014 Implants for surgery- Metallic materials Part 11: Wrought titanium 6-aluminium 7-niobium alloy or commercially pure titanium conforming to ISO 5832-2:2018 Implants for surgery- Metallic materials Part 2: Unalloyed titanium. The basal screws are manufactured from titanium alloy conforming to ISO 5832-11:2014. ## Summary of Nonclinical Testing Nonclinical testing data submitted or referenced to demonstrate substantial equivalence in this 510(k) includes: - Dynamic fatigue testing was performed on worst-case constructs, that were determined . for each connection type and implant body design, according to Root-form endosseous dental implants and endosseous dental abutments- class II special controls guidance document for industry and FDA staff and Guidance for industry and ISO 14801: 2016 Dentistry - implants - dynamic loading test for endosseous dental implant, - . Testing was performed to confirm that the Custom Abutments components are implemented correctly in within the digital workflow and the centralized workflow performs according to the requirements, - K203355 (Institut Straumann AG) referenced for steam sterilization validation according . to ISO 17665-1: Sterilization of health care products- Most heat- Part 1: Development, validation and routine control of a sterilization process for medical devices and ISO/TS 17665-2: Sterilization of health care products- Moist heat- Part 2: Guidance on the application of ISO 17665-1, - K190662 (Institut Straumann AG) referenced for MRI testing in accordance with ASTM . F2052-15, ASTM F2213-06 (2011), ASTM F2182-11a and ASTM F2119-13, - K190040 and K052272 (Institut Straumann AG) referenced for biocompatibility in . accordance with ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. {10}------------------------------------------------ #### Custom Abutments 510(k) Summary ## Conclusion The data included in this submission demonstrate substantial equivalence to the predicate device listed above. Performance testing and comparison to previous clearances show that the subject devices are substantially equivalent.